Severe Acute Respiratory Infection-Preparedness: Protocol for a Multicenter Prospective Cohort Study of Viral Respiratory Infections

Radu Postelnicu¹, Avantika Srivastava², Pavan K Bhatraju³, Mark M Wurfelc³, George L Anesi⁴, Martin Gonzalez⁵, Adair Andrews⁵, Karen Lutrick⁶, Vishakha K Kumar⁵, Timothy M Uyeki⁷, Perren J Cobb⁸, Leopoldo N Segal¹, David Brett-Major^{9

10}, Janice M Liebler¹¹, Christopher J Kratochvil¹⁰, Vikramjit Mukherjee¹, M Jana Broadhurst^{10

12}, Richard Lee¹³, David Wyles¹⁴, Jonathan E Sevransky^{15

16}, Laura Evans³, Douglas Landsittel¹⁷

Affiliations

¹ Division of Pulmonary, Critical Care, and Sleep Medicine, NYU Grossman School of Medicine, NYU Langone Health, New York, NY.
² Department of Biomedical Informatics, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
³ Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, Seattle, WA.
⁴ Division of Pulmonary, Allergy, and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
⁵ Society of Critical Care Medicine, Mount Prospect, IL.
⁶ Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ.
⁷ Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA.
⁸ Departments of Surgery and Anesthesiology, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA.
⁹ Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE.
¹⁰ Global Center for Health Security, University of Nebraska Medical Center, Omaha, NE.
¹¹ Division of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.
¹² Department of Pathology and Microbiology, College of Medicine, University of Nebraska Medical Center, Omaha, NE.
¹³ Division of Pulmonary Diseases and Critical Care Medicine, University of California, Irvine, CA.
¹⁴ Division of Infectious Diseases, Denver Health Medical Center, Denver, CO.
¹⁵ Division of Pulmonary, Allergy, Critical Care and Sleep, School of Medicine, Emory University, Atlanta, GA.
¹⁶ Emory Critical Care Center, Emory Healthcare, Atlanta, GA.
¹⁷ Department of Epidemiology and Biostatistics, School of Public Health, Indiana University, Bloomington, IN.

PMID: 36284548
PMCID: PMC9586923
DOI: 10.1097/CCE.0000000000000773

Severe Acute Respiratory Infection-Preparedness: Protocol for a Multicenter Prospective Cohort Study of Viral Respiratory Infections

Radu Postelnicu et al. Crit Care Explor. 2022.

. 2022 Oct 20;4(10):e0773.

doi: 10.1097/CCE.0000000000000773. eCollection 2022 Oct.

Authors

Affiliations

¹ Division of Pulmonary, Critical Care, and Sleep Medicine, NYU Grossman School of Medicine, NYU Langone Health, New York, NY.
² Department of Biomedical Informatics, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
³ Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, Seattle, WA.
⁴ Division of Pulmonary, Allergy, and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
⁵ Society of Critical Care Medicine, Mount Prospect, IL.
⁶ Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ.
⁷ Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA.
⁸ Departments of Surgery and Anesthesiology, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA.
⁹ Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE.
¹⁰ Global Center for Health Security, University of Nebraska Medical Center, Omaha, NE.
¹¹ Division of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.
¹² Department of Pathology and Microbiology, College of Medicine, University of Nebraska Medical Center, Omaha, NE.
¹³ Division of Pulmonary Diseases and Critical Care Medicine, University of California, Irvine, CA.
¹⁴ Division of Infectious Diseases, Denver Health Medical Center, Denver, CO.
¹⁵ Division of Pulmonary, Allergy, Critical Care and Sleep, School of Medicine, Emory University, Atlanta, GA.
¹⁶ Emory Critical Care Center, Emory Healthcare, Atlanta, GA.
¹⁷ Department of Epidemiology and Biostatistics, School of Public Health, Indiana University, Bloomington, IN.

PMID: 36284548
PMCID: PMC9586923
DOI: 10.1097/CCE.0000000000000773

Abstract

Respiratory virus infections cause significant morbidity and mortality ranging from mild uncomplicated acute respiratory illness to severe complications, such as acute respiratory distress syndrome, multiple organ failure, and death during epidemics and pandemics. We present a protocol to systematically study patients with severe acute respiratory infection (SARI), including severe acute respiratory syndrome coronavirus 2, due to respiratory viral pathogens to evaluate the natural history, prognostic biomarkers, and characteristics, including hospital stress, associated with clinical outcomes and severity.

Design: Prospective cohort study.

Setting: Multicenter cohort of patients admitted to an acute care ward or ICU from at least 15 hospitals representing diverse geographic regions across the United States.

Patients: Patients with SARI caused by infection with respiratory viruses that can cause outbreaks, epidemics, and pandemics.

Interventions: None.

Measurements and main results: Measurements include patient demographics, signs, symptoms, and medications; microbiology, imaging, and associated tests; mechanical ventilation, hospital procedures, and other interventions; and clinical outcomes and hospital stress, with specimens collected on days 0, 3, and 7-14 after enrollment and at discharge. The primary outcome measure is the number of consecutive days alive and free of mechanical ventilation (VFD) in the first 30 days after hospital admission. Important secondary outcomes include organ failure-free days before acute kidney injury, shock, hepatic failure, disseminated intravascular coagulation, 28-day mortality, adaptive immunity, as well as immunologic and microbiologic outcomes.

Conclusions: SARI-Preparedness is a multicenter study under the collaboration of the Society of Critical Care Medicine Discovery, Resilience Intelligence Network, and National Emerging Special Pathogen Training and Education Center, which seeks to improve understanding of prognostic factors associated with worse outcomes and increased resource utilization. This can lead to interventions to mitigate the clinical impact of respiratory virus infections associated with SARI.

Keywords: COVID-19; clinical research networks; hospitalized patients; observational study; severe acute respiratory syndrome coronavirus 2.

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Conflict of interest statement

Dr. Anesi receives research funding from the Agency for Healthcare Research and Quality and reports payments for authoring COVID-19 chapters for UpToDate and for expert witness consulting. Dr. Segal receives grant funding from the National Institutes of Health (Method to Extend Research in Time R37 CA244775) paid to institution, and Dr. Wyles receives funding from Gilead Sciences paid to institution (ended August 31, 2021). The remaining authors have disclosed that they do not have any potential conflicts of interest.

Figures

**Figure 1.**
Severe acute respiratory infection (SARI) preparedness network structure.

**Figure 2.**
Severe acute respiratory infection-preparedness (SARI-PREP) patient enrollment and clinical procedures. CCC = Clinical Coordinating Center, DCC = Data Coordinating Center, IRB = institutional review board.

See this image and copyright information in PMC

References

1. Lozano R, Naghavi M, Foreman K, et al. : Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2095–2128 - PMC - PubMed
1. Fitzner J, Qasmieh S, Mounts AW, et al. : Revision of clinical case definitions: Influenza-like illness and severe acute respiratory infection. Bull World Health Organ 2018; 96:122–128 - PMC - PubMed
1. World Health Organization. COVID-19 Weekly Epidemiological Update Edition 54. Published August 24, 2021. Available at: https://www.who.int/publications/m/item/weekly-epidemiological-update-on.... Accessed. October 29, 2021.
1. Ljungström LR, Jacobsson G, Claesson BEB, et al. : Respiratory viral infections are underdiagnosed in patients with suspected sepsis. Eur J Clin Microbiol Infect Dis 2017; 36:1767–1776 - PMC - PubMed
1. Hartman L, Zhu Y, Edwards KM, et al. : Underdiagnosis of influenza virus infection in hospitalized older adults. J Am Geriatr Soc 2018; 66:467–472 - PMC - PubMed

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Severe Acute Respiratory Infection-Preparedness: Protocol for a Multicenter Prospective Cohort Study of Viral Respiratory Infections

Affiliations

Severe Acute Respiratory Infection-Preparedness: Protocol for a Multicenter Prospective Cohort Study of Viral Respiratory Infections

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Grants and funding

LinkOut - more resources

Full Text Sources